QUETIAPINA 50 mg Таблетки С Пролонгированным Высвобождением

Содержание инструкции

1. QUETIAPINA DOC
   1. What is QUETIAPINA DOC and what is it used for
   2. What you need to know before taking QUETIAPINA DOC
   3. How to take QUETIAPINA DOC
   4. Possible side effects
   5. How to store QUETIAPINA DOC
   6. Package contents and other information

QUETIAPINA DOC

50 mg, 150 mg, 200 mg, 300 mg, 400 mg prolonged-release tablets
Generic medicine

Read this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What QUETIAPINA DOC is and what it is used for
• 2. What you need to know before you take QUETIAPINA DOC
• 3. How to take QUETIAPINA DOC
• 4. Possible side effects
• 5. How to store QUETIAPINA DOC
• 6. Contents of the pack and other information

1. What is QUETIAPINA DOC and what is it used for

QUETIAPINA DOC contains a substance called quetiapine. This substance belongs
to a group of medicines called antipsychotics. QUETIAPINA DOC can be used to
treat several illnesses, such as the following:

• Bipolar depression and major depressive episodes associated with major depressive disorder: you may feel sad. You may notice that you feel depressed, with feelings of guilt, lacking energy, lacking appetite or having difficulty sleeping.
• Mania: you may feel very excited, euphoric, agitated, enthusiastic or hyperactive or have poor judgement, including states of aggression or destructiveness.
• Schizophrenia: you have the sensation of hearing or perceiving things that are not actually present, you may become convinced of things that are not true or you may feel unusually suspicious, anxious, confused, guilty, tense or depressed.

When QUETIAPINA DOC is taken for the treatment of major depressive episodes
associated with major depressive disorder, it will be administered in addition to another
medicine used to treat this illness.
The doctor may continue to prescribe QUETIAPINA DOC even if you feel better.

2. What you need to know before taking QUETIAPINA DOC

Do not take QUETIAPINA DOC:
if you are allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6)
if you are taking any of the following medicines:
o some medicines for the Human Immunodeficiency Virus (HIV)
o azole medicines (for infections caused by fungi)
o erythromycin or clarithromycin (for infections)
o nefazodone (for depression)
Do not take QUETIAPINA DOC if you fall into one of the categories described above. If you have any doubts, ask your doctor or pharmacist before taking QUETIAPINA DOC.

Warnings and precautions
Talk to your doctor or pharmacist before taking QUETIAPINA DOC if:
you or someone in your family has or has had heart problems in the past, for example, irregular heartbeat, weakening of the heart muscle or inflammation of the heart, or if you are taking medicines that can affect your heartbeat
you have low blood pressure
you have had a stroke, especially if you are elderly
you have liver problems
you have had seizures (convulsions)
you have diabetes or are at risk of developing diabetes. In this case, your doctor may check your blood sugar levels while you are taking QUETIAPINA DOC
you know that you have had low levels of white blood cells in the past (whether or not caused by other medicines)
you are an elderly person with dementia (loss of some brain functions). In this case, you should not take QUETIAPINA DOC, because this class of medicines, to which QUETIAPINA DOC belongs, can increase the risk of stroke, or in some cases the risk of death in elderly patients with dementia
you or someone in your family has a history of blood clots, as medicines of this type can promote the formation of blood clots
you suffer from or have suffered from a condition that causes interruptions in breathing for short periods during normal sleep (called “sleep apnea”) and are also taking medicines that slow down normal brain activity (“central nervous system depressants”)
you suffer from or have suffered from a condition that prevents complete emptying of the bladder (urinary retention), have an enlarged prostate, suffer from a bowel obstruction, or have high pressure inside the eye. In some cases, these conditions are caused by medicines (called “anticholinergics”) that affect the functioning of nerve cells in order to treat certain diseases
you have or have had problems related to alcohol or drug abuse.

Tell your doctor immediately if you experience any of the following symptoms after taking QUETIAPINA DOC:
fever accompanied by severe muscle stiffness, sweating or decreased level of consciousness (a condition called “neuroleptic malignant syndrome”). Immediate medical attention may be necessary.
uncontrollable movements, mainly of the face or tongue;
dizziness or a strong feeling of drowsiness. This can increase the risk of accidental injuries (falls) in elderly patients;
seizures (convulsions);
persistent and painful erection (Priapism).
The following conditions may be caused by this type of medicine.
Tell your doctor as soon as possible if you experience:
Fever, flu-like symptoms, sore throat or any other infection, because they may be a consequence of a very low white blood cell count, which may require QUETIAPINA DOC to be stopped and/or treatment to be administered.
Constipation along with persistent abdominal pain or constipation that has not responded to treatment, as this may lead to a more serious bowel obstruction.

Thoughts of suicide and worsening of depression
If you are depressed, you may sometimes feel the need to harm yourself or kill yourself. These feelings may be more intense at the beginning of treatment, as these medicines need time to work, usually about two weeks but sometimes even longer.
These thoughts may also intensify if you suddenly stop taking the medicine. You are more likely to have these feelings if you are a young adult. Information from clinical studies has shown an increase in the risk of suicidal thoughts and/or suicidal behavior in young adults with depression under the age of 25.
If at any time you realize you are having thoughts of self-harm or suicide, contact your doctor or go to the hospital immediately.
It may be helpful to tell a family member or close friend that you are depressed, that your depression is getting worse, or if they are worried about changes in your behavior.

Weight gain
Weight gain has been reported in patients treated with quetiapine. It is necessary that your body weight is checked regularly by you and your doctor.

Children and adolescents
QUETIAPINA DOC should not be used in children and adolescents under the age of 18 years.

Other medicines and QUETIAPINA DOC
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Do not take QUETIAPINA DOC if you are taking any of the following medicines:
some medicines for the Human Immunodeficiency Virus (HIV);
azole medicines (for infections caused by fungi);
erythromycin or clarithromycin (for infections);
nefazodone (for depression).
Tell your doctor if you are taking any of the following medicines:
medicines for epilepsy (such as phenytoin or carbamazepine);
medicines for high blood pressure;
barbiturates (for sleep disorders);
thioridazine or lithium (other antipsychotic medicines);
medicines that affect the heartbeat, for example, medicines that can cause an electrolyte imbalance (low levels of potassium or magnesium) such as diuretics (pills that increase urine production) or some antibiotics (medicines for the treatment of infections);
medicines that can cause constipation;
medicines (called “anticholinergics”) that affect the functioning of nerve cells in order to treat certain diseases.
Before stopping taking any medicine, talk to your doctor.

QUETIAPINA DOC with food, drinks and alcohol
The effect of QUETIAPINA DOC may be affected by food and therefore you should take the tablets at least one hour before a meal or before going to bed.
Be careful about the amount of alcohol you consume. This is important because the combined effect of QUETIAPINA DOC and alcohol can promote drowsiness.
Do not drink grapefruit juice while taking QUETIAPINA DOC, as it may affect the action of the medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.
Do not take QUETIAPINA DOC during pregnancy without first discussing it with your doctor. QUETIAPINA DOC should not be taken during breastfeeding.
The following symptoms, which may represent withdrawal, have been observed in newborns of mothers who have taken quetiapine during the last trimester (the last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems and difficulty feeding. If your baby shows any of these symptoms, contact your doctor.

Driving and using machines
The tablets can cause drowsiness. Do not drive or use any tools or machinery until you know what effect the tablets have on you.

Effect on urine screening tests
If you need to undergo a urine screening test, taking QUETIAPINA DOC may lead to false positive results for methadone or for some medicines for depression, called tricyclic antidepressants (TCAs) when certain test methods are used, even if you are not taking methadone or TCAs. If this happens, more specific tests must be performed.

QUETIAPINA DOC contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take QUETIAPINA DOC

Take this medicine following exactly the instructions of your doctor. If you have
doubts, consult your doctor or pharmacist.
The doctor will decide what is the most appropriate initial dose for you. The maintenance
dose (daily dose) will depend on the type of illness and individual needs, but
usually is between 150 mg and 800 mg.
You must take the tablets once a day.
Do not split, chew or break the tablets.
Swallow the tablets whole, with a glass of water.
Take the tablets away from meals (at least one hour before a meal or at bedtime, the doctor
will tell you when).
Do not drink grapefruit juice during treatment with QUETIAPINA DOC because it may
influence the action of the medicine.
Do not stop taking the tablets even if you feel better, unless your
doctor tells you to.

Liver problems
If you have liver problems, your doctor may modify the dose.

Elderly
If you are elderly, your doctor may modify the dose.

Use in children and adolescents
QUETIAPINA DOC should not be used in children and adolescents under 18
years of age.

If you take more QUETIAPINA DOC than you should
If you take more QUETIAPINA DOC than prescribed by your doctor, you may feel sleepy,
experience dizziness and perceive an abnormal heartbeat. Contact your
doctor or the nearest hospital immediately. Bring with you the package of QUETIAPINA DOC.

If you forget to take QUETIAPINA DOC
If you forget to take a dose, take it as soon as you remember. If it is almost time to
take the next dose, wait until the scheduled time. Do not take a double dose to
make up for the forgotten tablet.

If you stop taking QUETIAPINA DOC
If you suddenly stop treatment with QUETIAPINA DOC, you may have
difficulty sleeping (insomnia), feel unwell (nausea), or experience headache, diarrhea, a
feeling of illness (vomiting), dizziness or irritability.
The doctor may suggest that you gradually reduce the dose before stopping the
treatment.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Not all people will experience them.

Very common (may affect more than 1 in 10 people):

• Dizziness (may cause falls), headache, dry mouth.
• Feeling sleepy (which disappears over time, continuing treatment with QUETIAPINA DOC) (may cause falls).
• Withdrawal symptoms (symptoms that appear when you stop taking QUETIAPINA DOC), which include inability to fall asleep (insomnia), nausea, headache, diarrhea, vomiting, dizziness and irritability. Gradual discontinuation of the medicine is recommended, over a period of at least 1 or 2 weeks.
• Weight gain.
• Abnormal muscle movements, including difficulty starting a muscle movement, tremor, feeling restless or muscle stiffness without pain.
• Changes in the amount of certain fats (triglycerides and total cholesterol).

Common (may affect up to 1 in 10 people):

• Fast heartbeat.
• Feeling that the heart is racing, beating strongly or feeling of missed beats.
• Constipation, stomach discomfort (indigestion).
• Feeling of weakness.
• Swelling of the arms or legs.
• Low blood pressure when standing up. This can cause dizziness or fainting (which can cause falls).
• Increased blood sugar levels.
• Blurred vision.
• Strange dreams and nightmares.
• Increased feeling of hunger.
• Irritability.
• Speech and language disorders.
• Suicidal thoughts and worsening of depression.
• Shortness of breath.
• Vomiting (especially in the elderly).
• Fever.
• Changes in the amount of thyroid hormones in the blood.
• Decreases in the number of certain types of blood cells.
• Increases in the amount of liver enzymes measured in the blood.
• Increases in the amount of the hormone prolactin in the blood. Increases in the hormone prolactin may, in rare cases, lead to the following: o Men and women may experience breast enlargement and unexpected milk production. o Women may experience absent or irregular menstrual cycles.

Uncommon (may affect up to 1 in 100 people):

• Convulsions or seizures.
• Allergic reactions including swelling (hives), skin swelling and swelling around the mouth.
• Unpleasant sensation in the legs (also called restless legs syndrome).
• Difficulty swallowing.
• Involuntary movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Alteration of the electrical activity of the heart detected on an ECG (prolongation of the QT interval).
• A slowing of the normal heartbeat that can occur when starting treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (may cause falls).
• Nasal congestion.
• Decrease in the number of red blood cells.
• Decrease in the amount of sodium in the blood.
• Worsening of pre-existing diabetes.

Rare (may affect up to 1 in 1,000 people):

• High body temperature (fever) associated with sweating, muscle rigidity, increased feeling of stiffness or fainting (a condition called “neuroleptic malignant syndrome”).
• Yellowing of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis).
• Persistent and painful erection (priapism).
• Breast enlargement and unexpected milk production from the mammary gland (galactorrhea).
• Menstrual disorders.
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the legs), which can move through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, contact your doctor immediately.
• Walking, talking, eating or other activities while sleeping.
• Decrease in body temperature (hypothermia).
• Inflammation of the pancreas.
• A condition (called “metabolic syndrome”) in which you may have a combination of 3 or more of the following symptoms: increased fat around the abdomen, decreased “good” cholesterol (HDL-C), increased type of fat in the blood called triglycerides, high blood pressure and increased blood sugar levels.
• Association of fever, flu-like symptoms, sore throat or any other infection with a very low white blood cell count, a condition called agranulocytosis.
• Bowel obstruction.
• Increase in the blood of creatine phosphokinase (a substance from muscles).

Very rare (may affect up to 1 in 10,000 people):

• Severe skin rash, blisters or red patches on the skin.
• Severe allergic reaction (called anaphylaxis), which can cause difficulty breathing or shock.
• Rapid swelling of the skin, usually in the area around the eyes, lips and throat (angioedema).
• Severe condition characterized by blistering of the skin, in the mouth, eyes and genitals (Stevens-Johnson syndrome).
• Inappropriate secretion of the hormone that controls urine volume.
• Damage to muscle fibers and muscle pain (rhabdomyolysis).

Frequency not known (frequency cannot be estimated from the available data):

• Skin rash associated with the appearance of irregular red patches (erythema multiforme).
• Severe sudden allergic reaction with symptoms such as fever, blistering of the skin and skin peeling (toxic epidermal necrolysis).
• Withdrawal symptoms may occur in newborns of mothers who have used quetiapine during pregnancy.

The class of medicines to which QUETIAPINA DOC belongs can cause problems with the
heart rhythm, which can be serious and life-threatening in some cases.
Some side effects are only visible after a blood test. These include changes in the amount of certain fats (triglycerides and total cholesterol) or
sugars in the blood, changes in blood levels of thyroid hormones, increased
liver enzymes, decreased number of certain types of blood cells, the
decrease in the amount of red blood cells, increased serum creatine phosphokinase (a
substance present in muscles), decreased amount of sodium in the blood, and
increases in the amount of the hormone prolactin present in the blood. Increases in the levels
of the hormone prolactin may, in rare cases, have the following consequences:
o Men and women may experience breast enlargement and unexpected milk
production.
o Women may experience absent or irregular menstrual cycles.
The doctor will therefore prescribe you blood tests from time to time.

Side effects in children and adolescents
The same side effects observed in adults can also occur in children and
adolescents.
The following side effects have been observed more frequently in children and adolescents or have not been reported in adults:

Very common (may affect more than 1 in 10 people):

• Increased levels in the blood of a hormone called prolactin. Increases in the hormone prolactin may, in rare cases, lead to the following: o Boys and girls may experience breast enlargement and unexpected milk production o Girls may experience absent or irregular menstrual cycles
• Increased appetite
• Vomiting
• Abnormal muscle movements, including difficulty starting a muscle movement, tremor, feeling restless or muscle stiffness without pain.
• Increased blood pressure.

Common (may affect up to 1 in 10 people):

• Weakness, fainting (may cause falls)
• Nasal congestion
• Irritability

Reporting of side effects
If you get any side effects, even those not listed in this leaflet,
tell your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
http:// www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects you can help provide more information on
the safety of this medicine.

5. How to store QUETIAPINA DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after
“Exp”. The expiry date refers to the last day of that month.
QUETIAPINA DOC does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What QUETIAPINA DOC contains

• The active ingredient is quetiapine. QUETIAPINA DOC contains 50 mg, 150 mg, 200 mg, 300 mg or 400 mg of quetiapine (as quetiapine fumarate).
• Other ingredients are: Tablet core: anhydrous lactose, methacrylic acid-ethyl acrylate copolymer (1:1), type A, crystalline maltose, magnesium stearate and talc. Tablet coating: methacrylic acid-ethyl acrylate copolymer (1:1), type A, triethyl citrate.

Description of the appearance of QUETIAPINA DOC and package contents
The 50 mg prolonged-release tablets are tablets of colour from white to off-white, round, biconvex with ‘50’ inscribed on one side, 7.1 mm in diameter and 3.2 mm
in thickness.
The 150 mg prolonged-release tablets are tablets of colour from white to off-white, oblong, biconvex with ‘150’ inscribed on one side, 13.6 mm in length, 6.6
mm in width and 4.2 mm in thickness.
The 200 mg prolonged-release tablets are tablets of colour from white to off-white, oblong, biconvex with ‘200’ inscribed on one side, 15.2 mm in length, 7.7
mm in width and 4.8 mm in thickness.
The 300 mg prolonged-release tablets are tablets of colour from white to off-white, oblong, biconvex with ‘300’ inscribed on one side, 18.2 mm in length, 8.2
mm in width and 5.4 mm in thickness.
The 400 mg prolonged-release tablets are tablets of colour from white to off-white, oval, biconvex with ‘400’ inscribed on one side, 20.7 mm in length, 10.2 mm
in width and 6.3 mm in thickness.
QUETIAPINA DOC is available in PVC/PCTFE-aluminium blisters placed in a cardboard box.
QUETIAPINA DOC 50 mg: 10, 20, 30, 50, 60 and 100 tablets.
QUETIAPINA DOC 150 mg: 10, 20, 30, 50, 60 and 100 tablets.
QUETIAPINA DOC 200 mg: 10, 20, 30, 50, 60 and 100 tablets.
QUETIAPINA DOC 300 mg: 10, 20, 30, 50, 60 and 100 tablets.
QUETIAPINA DOC 400 mg: 10, 20, 30, 50, 60 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
DOC Generici S.r.l., Via Turati 40, 20121 Milan, Italy.

Manufacturers:
Pharmathen International S.A
Industrial Park Sapes, Rodopi Perfecture, Block 5, 69300 Rodopi, Greece.
Pharmathen S.A.
6, Dervenakion str., Pallini, Attikis, 15351 Greece.

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria Queloran 50 mg, 150mg, 200mg, 300mg, 400mg Retardtabletten
Cyprus Queloran
Germany Quetiapin-Hormosan 50 mg, 150mg, 200mg, 300mg, 400mg
Retardtabletten
Denmark Antoreq
Greece Megazon
Spain Quetiapina Apotex
Finland Queloran
Italy QUETIAPINA DOC
Portugal Queloran
Sweden Quetiapin 1A Farma
United Kingdom Zaluron XL